TWIN BUN/GLUCOSE— 510(k) K861775

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K861775 for TWIN BUN/GLUCOSE, Substantially Equivalent on 1986-06-27. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code CDW
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1986-05-08
Decision date: 1986-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDW

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K863425 — AMRESCO FLOW PAC UREA NITROGEN REAGENTS #13461986-10-01
K860419 — UREA NITROGEN REAGENT SET1986-02-11
K850937 — UREA1985-06-10

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Data sourced from openFDA. This site is unofficial and independent of the FDA.